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Posted by Nate Herpich, January 21, 2013

An important step toward finding a critically-needed drug for a largely untreated Parkinson's symptom

A clinical trial of a drug to treat cognitive dysfunction in Parkinson's disease (PD) is today enrolling its first participants, an announcement that lends hope to a largely barren drug landscape for people dealing with this symptom.

MJFF first announced this unique partnership with Sanofi last spring: The Foundation is sponsoring a phase 1b clinical trial of Sanofi's drug candidate AVE8112, which was previously in development for Alzheimer's disease, and which has shown promise in pre-clinical models of cognition. This is the first time that this drug will be tested in Parkinson's patients, so researchers will be looking to find out how safe the drug is for those on PD drug regimens.

The launch also marks the first time that the Foundation has successfully completed an Investigational New Drug Application with the Food and Drug Administration, a necessary step in bringing a new drug into a clinical trial. Usually, this type of role is reserved for pharmaceutical companies, but by having a seat at the table, the Foundation is able to provide a unique perspective from the viewpoint of both the researcher and the patient. This is good news for beginning to establish a working relationship with the government around how to better understand cognitive decline as a real symptom of PD, and for also establishing the framework for future clinical studies into drugs that could address it.

This is important, because, while cognitive dysfunction is a troublesome reality for many people living with Parkinson's, it is not well-understood. Symptoms can range from slowness of thinking or difficulty organizing and sequencing one's thoughts, to memory loss, to the eventual onset of dementia. The only approved therapy currently on the market for PD dementia is the Exelon Patch (rivastigmine) which only modestly improves symptoms.

An overriding hurdle to drug development for cognitive decline is that little is known about the underlying disease processes taking place in the brain.

"Cognitive dysfunction is marked by a big mixed bag of pathology," said Jamie Eberling, PhD, associate director of research programs at MJFF, when the clinical trial was originally announced. "Different processes in different parts of the brain affect individuals with Parkinson's in different ways."

Researchers believe that multiple systems are at work in cognitive dysfunction in PD, including the dopaminergic system known for its role in the motor symptoms of the disease. Another neurotransmitter called norepinephrine has piqued researchers' interest due to its role in both PD and in cognitive decline across several disorders. Serotonin, known to play a part in depression, could also affect cognitive ability. A frequent target for Alzheimer's drug development called acetylcholine seems to also play a role in PD.

The Foundation continues to support studies looking at each of these potential targets.